Clinical Safety and Pharmacovigilance Track at DIA2013

 

Do you know how to recognize the impact of benefit-risk assessment in safety data?

What are the new international standards and terminologies for reporting to EudraVigilance?

How does Risk Communication differ in US and EU?

What is the likelihood ratio test-based signal detection method for FDA’s AERS database?

What is the EMA doing to improve benefit-risk assessment of medicines?

What are the current challenges in monitoring BP through the different indications and in the different trial phases?

What are differences in legislation for risk management between the US, EU and Japan?

How can coding with MedDRA® improve clinical safety data?

What are recent innovations driving patient-focused approach to benefit-risk in Canada?

What is the relevance and application of drug interaction predictive models to clinical development?

How can I obtain higher-quality narrative information from patients through traditional and new media?

How can I generate metrics for the effectiveness and efficiency of a signal detection program?

How do I use social media, mobile apps and patient support programs for pharma and biotech industries?

What is the ongoing international standardization work on ICSR and IDMP?

What are recommendations from projects of the Clinical Trials Transformation Initiative?

How can I anticipate factors that may increase the incidence of drug shortages in the future?

What are the initiatives using electronic health records for drug safety signal detection and evaluation?

How can Herbal-induced Organ Toxicity impact Rx Benefit-risk?

How do I compile a PSUR according to the new EU and ICH guidance?

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

What are the current methods of tracking misuse and abuse of marketed pharmaceuticals?

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For our friends in Japan, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

 

For our friends in Japan, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         

What are the areas of potential risks when undertaking global clinical trials in emerging markets?
GCPs in Emerging Countries
What are the GCP quality trends in US and emerging countries?

Risk Management in the US, EU and Japan: The Challenges of Diversity

What are differences in legislation for risk management between the US, EU and Japan?
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
PMDA Town Hall: Japanese regulation activities and initiatives

Challenges for Stable Supply of Drugs and International Cooperation

What is the current drug supply situation in US, EU and Japan?

Pharmacovigilance Update for Japan, Developing Asia and Latin America

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

A Regulatory Perspective of Biosimilars in Emerging Markets

What are similarities/differences in Biosimilar regulatory requirements in APAC and Latin America?


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Oportunidades de Capacitación para Mejorar su Desarrollo Profesional

La DIA, entiende  que a la vez que usted cumple con sus ocupaciones necesita mejorar sus habilidades y mantenerse actualizado sobre las novedades de la industria-- todo dentro de su horario de trabajo. Es por eso que la DIA ha creado Programas de Certificación que ofrecen instrucción interactiva impartida por expertos en el ramo, conveniente para su campo laboral.   Los Programas de Certificación de la DIA ofrecen capacitación real que fomente su desarrollo profesional. Muchos de nuestros programas ofrecen créditos de educación continua y Certificados de Terminación expedidos por la DIA.   Los Programas de Certificación se ofrecen en cuatro áreas clave. Haga clic en su campo de su interés para obtener más información sobre el programa a la medida que le interese: Seguridad Clínica y Farmacovigilancia Gestión de proyectos Asuntos Regulatorios Investigación Clínica Otros Eventos Programa de Certificación en Seguridad Clínica y Farmacovigilancia Instructores de clase mundial de la DIA abordan aspectos teóricos y prácticos sobre la aplicación de la farmacovigilancia, con  un enfoque especial  en la comprensión de temas que abarcan desde procesos efectivos hasta los principios básicos del cumplimiento de normas regulatorias internacionales, así como los principios de seguridad. Temas principales: Pre y post-mercadeo en seguridad clínica y farmacovigilancia Estrategias de gestión de riesgo Cómo prepararse para una inspección de seguridad Enfoque médico en diagnóstico y tratamiento de las reacciones adversas a los medicamentos Señal de detección y gestión de datos Vigilancia del Manejo Seguro de Medicamentos y epidemiología   Descargar Requisitos del Programa     Formulario de inscripción   Programa de Certificación sobre Gestión de Proyectos El Programa de Certificación de Gestión de Proyectos de DIA le ofrece una amplia selección de cursos que ayudarán a los profesionales a reducir los tiempos de los ciclos de desarrollo de productos, a mejorar la calidad del producto y asegurar su rentabilidad. Temas principales: Retos actuales en la gestión de proyectos Planificación y gestión de proyectos Programación, recursos y manejo de costos Construcción de equipos y comunicaciones Gestión de riesgos Paradigmas para el desarrollo de fármacos   Descargar Requisitos del Programa     Formulario de inscripción   Programa de Certificación en Asuntos Regulatorios Este programa le proporciona una formación integral en la normativa vigente y su aplicación práctica para su desarrollo, comercialización de productos farmacéuticos, biotecnología, dispositivos médicos y productos relacionados con el cuidado de la salud.   Temas principales: Asuntos regulatorios de los EE.UU: las fases IND y NDA Requisitos regulatorios de los EE. UU. Preparación para los encuentros con la FDA Requisitos Regulatorios Post- Aprobación Requisitos reglamentarios para el etiquetado y publicidad de productos Cursos de regulación que cubren lo relativo a medicamentos, dispositivos médicos y productos biológicos Control de calidad   Descargar Requisitos del Programa     Formulario de inscripción   Programa de Certificación sobre Investigación Clínica Instructores de clase mundial de la DIA ofrecen un plan de estudios único que combina los principios de negocio, la comprensión de las buenas prácticas de investigación clínica, así como también el desarrollo de las habilidades necesarias para enfrentar los cambiantes escenarios políticos, regulatorios y financieros. Temas principales: Buenas prácticas clínicas Fundamentos de Investigación clínica y seguimiento Estadísticas clínicas para personal no familiarizado Gestión de proyectos clínicos Elaboración de reportes sobre estudios clínicos   Descargar Requisitos del Programa     Formulario de inscripción   ¿Desea llevar a su empresa un entrenamiento In-company? Permita que la DIA le diseñe el programa de capacitación in-company (en su sitio de trabajo) adecuado, una experiencia de formación que le permita alcanzar objetivos y metas específicas, todo esto a la medida del presupuesto y calendario de su organización. Vaya a www.diahome.org/Incompany; llene una forma de consulta o llame a Alejandro Bermudez-Del Villar al Telefono +1.215.293.5825 o por correo electrónico Alejandro.Bermudez@dialatinamerica.org

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Global Regulatory Track at DIA's 49th Annual Meeting

CBER Town Hall: Ongoing initiatives, guidances, and regulations

CDER Town Hall: Hot topics in drug development and regulation (part 1)/(part 2)

PMDA Town Hall: Japanese regulation activities and initiatives

What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?

What is the current regulatory system and government R&D program?

European Town Hall: Implementation of New Safety Legislation

What do stakeholders need to know about the Canada-US #RCC?

What is the current drug supply situation in US, EU and Japan?

What are Canadian approaches to Regulatory Modernization and Int'l Engagement?

Latin America Town Hall: How are LA regulations modeled after and differ from EMA and FDA regulations?

Nonclinical and Translational /Early Phase Clinical Development Track at DIA's 49th Annual Meeting

 

	How can we optimize the transition from Preclinical to Clinical Research?
	How can we design a strategy for efficient, rapid and inexpensive assessment of drug-related QT effects?
	What is the Impact of Subject Dual Enrollment on Study Data Validity?
	What are the opportunities for drug-induced vacsulitis biomarkers and translational medicine research areas.
	What are the benefits of PET imaging in preclinical and clinical therapeutic drug development?
	What is the impact of Pharmacometrics in Preclinical to Early Phase Clinical Development?
	When are human abuse liability studies indicated by FDA?
	What is the impact of regional cooperation on drug development innovation in China and Latin America?

Join high-profile global regulators, industry professionals, and academia to discuss current regulatory landscape in Latin America

Plan your Attendance at LARC 2013 Take a look at this overview of the insightful sessions coming to the Latin American Regulatory Conference (LARC) 2013. Not registered yet? Book your seat before April 12 to save with an early-bird discount! Join high-profile global regulators, industry professionals, and academia to discuss the current regulatory landscape and its impact on future research and drug development at the event in Bogota, Colombia from May 15-16. Find Out More Download the Program Register 2012 VIDEO HIGHLIGHTS Watch videos from last year’s Latin American conferences and get a taste of what you can expect from these insightful events in 2013. IT ONLY TAKES A FEW MINUTES... Update your customer profile to ensure that you receive communications tailored to your specific area(s) of interest. Session Highlights Updates on Regional and Global Convergence with perspectives from Chile, Colombia, Canada, the PAHO and WHO Latin American Agencies Profiles by CIRS: Number of Reviewers, Inspectors, Timeliness, Predictability and Quality of a Full Review Case Study: Challenges faced by Regulators in the Adoption of Internationally Recognized Technical Guidance Documents and Standards Risk Based Approach to Inspections Integrity of the Supply Chain: Serialization, Counterfeits and Disposal of Expired Drugs Transparency of Review Process Health Technology Assessment Implementation of e-Submissions “Miracle” Drugs and Pharmaceutical Products Bordering Dietary Supplement Find Out More Download the Program Register

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Highlights for upcoming Latin American Regulatory Conference - May 15-16, Bogota

Check out the Highlights for LARC 2013 Download the program and see what’s in store at the Latin American Regulatory Conference (LARC) 2013. Join global regulators, industry professionals and academia to discuss the current regulatory landscape and its impact on future research and drug development at the event in Bogota, Colombia from May 15-16. The LARC 2013 will focus on “Pharma-Co-Vergence” – the act of achieving pharmaceutical regulatory convergence through stakeholders’ collaboration – highlighting the true collaborative spirit of this multidisciplinary global conference. Attendees will learn how to define the various initiatives related to global regulatory environment and their impact on the access of medicines and future R&D in Latin America, and discuss the progress of the Pan American Network for Drug Regulatory Harmonization (PANDRH) convergence process and working groups. Download the Program Read More Register 2012 VIDEO HIGHLIGHTS Watch videos from last year’s Latin American conferences and get a taste of what you can expect from these insightful events in 2013. IT ONLY TAKES A FEW MINUTES... Update your customer profile to ensure that you receive communications tailored to your specific area(s) of interest. Featured Topics Regulatory Landscape and Convergence Initiatives Strengthening the Regulatory Framework Efforts Underway by Convergence Initiatives Reviews and Inspections Ethics Committee Research in the Regions Post-market Research Studies and Better Medicines to Influence Efficacy and Effectiveness Perspectives and Regulations of Pediatric Studies Drug Safety, Marketing Surveillance and Quality Control Monitoring Regulatory Concerns: Health Systems and Security of the Supply Chain Current Regulations of Biologics and Biosimilars Emerging Topics Who Should Attend Professionals involved in: Regulatory affairs Clinical research and development Clinical safety and pharmacovigilance Clinical trial and project management Drug development and discovery Medical and scientific affairs Preclinical development Quality assurance Research and development Strategic sourcing/planning Download the Program Read More Register

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